Identity
- Trade Name
- INSTI HIV-1 Control Test Kit FDA UDI
- Generic Name
- HIV1/HIV2 antibody IVD, control FDA UDI
- Device Name
- INSTI HIV-1 Control Test Kit FDA UDI
- Model / Reference
- 90-1030 FDA UDI
- Description
- INSTI HIV-1 Control Test Kit FDA UDI
Identifiers
- Catalog Number
- 90-1030 FDA UDI
- Primary DI / UDI-DI
- 00686597010303 FDA UDI
- FDA Product Code
- MZF FDA UDI
- GMDN Term
- HIV1/HIV2 antibody IVD, control FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3956 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
INSTI HIV-1 Control Test Kit by Biolytical Laboratories Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biolytical Laboratories Inc
Sources (1)
- FDA UDI e5ceb781-9208-45a8-b4ea-8d1c36a9ef0e 37 fields · synced Jun 6, 2026